The invention relates to percutaneous access catheters for providing access to internal body cavities and organs via a surgically induced access tract. More particularly, the invention relates to percutaneous access catheters having inflation elements for securing the placement of the catheter within the access tract, for coupling the internal body cavity or organ to the access tract, for preventing migration of the catheter within the internal body cavity or organ, and for controlling hemorrhage from the access tract by the application of tamponage.
It is known to employ inflation elements in conjunction with percutaneous access catheters for performing a variety of functions. For example, a Foley type drainage catheter can be employed for draining bile fluids by percutaneously inserting the catheter into a transhepatic tract or channel leading to a cholecystostomic opening within the gallbladder or biliary tree. The distal end of the Foley catheter conventionally includes a toroidal inflatable balloon proximal to the drainage port. When the toroidal balloon is inflated, it becomes larger than the ostomic opening and, consequently, restricts the withdrawal of the port from the biliary tree. If the Foley balloon is pulled tightly against the ostomic opening, the balloon can also serve to occlude the ostomic opening so as to prevent or reduce the leakage of bile fluids from the biliary tree into the transhepatic tract. It is also known to employ inflation elements in conjunction with percutaneous dilation catheters of the type used for dilating strictures and/or stenoses. Such a dilation catheter can be employed to increase fluid flow within an internal body cavity or organ. For example, balloon catheters for dilating biliary strictures and stenoses are described by both Liguory et al. and by Trambert et al. Both Liguory and Trambert teach that balloon catheters may be percutaneously inserted into an ostomic opening within the biliary tree and positioned therein for dilating strictures and stenoses. [Liguory, I. et al.: "Dilation Intrumentale et Cholangioscopie Transpariento-hepatique pour Stenose d'Anastonose Choledoco-duodenale avec Empierrement." L: Press Medicale (1986), vol. 15 (10), pages 481-483; Trambert, Jonathan et al.: "Percutaneous Transhepatic Balloon Dilation of Benign Biliary Strictures," American Journal of Roentgenology (1987), vol. 149 pages 945-948].
It is also known to employ inflation elements in conjunction with percutaneous dilation catheters of the type used for enlarging the diameter of an access tract. Such a dilation catheter can be employed to prepare an access tract for insertion of a percutaneous access catheter. For example, one such dilation catheter is described by Rutner, i.e. the Cook Enforcer (TM) Balloon Catheter. [Rutner, A. B.: "Percutaneous Nephrolithotripsy through a Fresh Tract Facilitated by Working Through a Separate Cannula or Sheath," paper presented at the Western Section AUA, 1985] Further examples of percutaneous dilation catheters are provided by Clayman et al and by Dorfman et al. [Clayman, Ralph V. and Castaneda Zuniga, Wilfrido: Techniques in Endourology: A Guide to the Percutaneous Removal of Renal and Ureteral Calculi, Chapter 5, "Dilation of the Nephrostomy Tract" pages 113-120 (Year Book Medical Publishers, Chicago & London - 1984); Dorfman, Gary S. Esparza, Alfredo R., and Cronan, John J.: Investigative Radiology, vol. 23, pages 441-446 (June 1988), "Percutaneous Large Bore Venotomy and Tract Creation: Comparison of Sequential Dilator and Angioplasty Balloon Methods in a Porcine Model--Preliminary Report."] A conventional protocol for the use of such a dilation catheter teaches that the initial access tract may be formed by means of a puncture with a needle or canula. The needle may include a guidewire within its lumen. When the needle is withdrawn from the access tract, the guidewire is left behind. A dilation catheter may then be inserted over the guidewire into the access tract. The balloon of the dilator may then be activated so as to enlarge the diameter of the access tract. If a relatively large access tract is desired, a series of dilators may be employed for increasing the diameter of the access tract step-wise. When inflated, the balloon of each dilator within the series dilates the tract to a size which then allows the next dilator to be inserted into the tract without significant tissue damage. Both Clayman and Dorfman indicate that, when a series of increasingly larger dilators is employed to dilate a percutaneous tract, the smallest incremental increase with respect to the size of each successive dilator within the series is 2 French. Accordingly, the difference in size between the fully inflated and fully deflated states of any of the balloons within the series of dilators must equal or exceed 2 French. Otherwise, clinically significant tissue damage could occur during a serial dilation procedure if, after dilating an access tract by less than 2 French, an attempt were then made to insert the next larger sized dilator into the tract.
And finally, it is also known to employ inflation elements in conjunction with percutaneous tamponade catheters. Routh et al. disclose that, if the insertion of a percutaneous drainage catheter causes acute hemorrhaging from an access tract, the hemorrhaging may be controlled by temporarily removing the percutaneous drainage catheter and inserting and activating an angioplasty balloon catheter. However, before the angioplasty balloon catheter is activated, it should be aligned with the arterial hemorrhage by angiography. Once hemorrhaging is controlled, the angioplasty balloon catheter may be deflated and removed and the percutaneous drainage catheter may be re-inserted. [Routh, William et al.: "Tube Tamponade: Potential Pitfall in Angiography of Arterial Hemorrhage Associated with Percutaneous Drainage Catheters," Radiology, vol. 174, pages 945-949.]